F1CHAPTER 10POWERS AND FURTHER DUTIES OF THE SECRETARY OF STATE

Article 31Power to amend the annexes

1.

The Secretary of State may by regulations amend—

(a)

Annex 1 where the Secretary of State considers there is sufficient scientific evidence that it is necessary to do so to ensure the safety of cosmetic products;

(b)

Annexes 2 to 6 where the Secretary of State considers that there is sufficient scientific evidence that there is a potential risk to human health arising from the use of a substance in a cosmetic product;

(c)

Annexes 2 or 3 where the Secretary of State considers that there is insufficient data to be able to determine whether there is a potential risk to human health;

(d)

Annexes 3 to 6 and 8 where the Secretary of State considers that there is sufficient scientific evidence that it is necessary to do so to take technical progress into account;

(e)

Annex 4 to extend its scope to hair colouring products.

(f)

Annex 2 to add a substance classified as a CMR substance of category 1A, 1B or 2 under Regulation (EC) No 1272/2008;

(g)

Annexes 3 to 6—

(i)

to allow a substance classified as a CMR substance of category 2 under Regulation (EC) No 1272/2008 to be used in cosmetic products where the Secretary of State considers that there is sufficient scientific evidence that the substance is safe for use in cosmetic products;

(ii)

to allow a substance classified as a CMR substance of category 1A or 1B under Regulation (EC) No 1272/2008 to be used in cosmetic products where the conditions in point (h) are met;

(iii)

to make provision as to labelling in order to implement Article 15(2);

(h)

the conditions referred to in point (g)(ii) are that—

(i)

the CMR substance complies with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

(ii)

an analysis of alternative substances has been undertaken and concluded that there are no suitable alternative substances available;

(iii)

an application to the Secretary of State is made for a particular use of the product category with a known exposure;

(iv)

the Secretary of State considers that there is sufficient scientific evidence that the CMR substance has been evaluated and found safe for use in cosmetic products; and

(v)

the evaluation referred to in point (iv) took into account exposure to the product and overall exposure to the CMR substance from other sources, particularly for vulnerable population groups.